EMA, HMA Issue Common Draft Strategy


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-31-2015 08:36

  

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released the "EU Medicines Agencies Network Strategy to 2020," a draft common strategy to 2020 for the European medicines agencies network, for a three-month public consultation. Stakeholders are invited to send their comments before June 3, 2015. The document under consultation outlines for the first time joint key priorities for the network and a high level strategy to achieve these.

The need to further strengthen the collaboration between the members of the network and work together towards achieving agreed goals has become more urgent recently," said EMA in a statement. "Europe faces the global threat represented by antimicrobial resistance to human and animal health, and needs to be prepared for emerging epidemics, as reminded by the outbreak of Ebola Virus Disease in West Africa in March 2014. At the same time the healthcare needs of patients in Europe are changing. Advancements in science and medicine mean that new and more complex medicines are being developed, which may bring opportunities for personalized medicines and more treatments for rare diseases. Patients also require timely access to new, beneficial and safe medicines. The globalization of the pharmaceutical industry means that greater collaboration with regulators beyond the European Union (EU) is essential to assure the supply of safe, effective and good quality medicines for humans and animals."

The joint strategy for the European medicines agencies network is based on a coordinated approach and a strengthened collaboration within the network over the next five years, to address the challenges and make the most of the opportunities to benefit human and animal health.

The networkt includes all national medicines regulatory authorities for both human and veterinary medicines from EU Member States and the European Economic Area (EEA), united in the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA). By working closely together, the network can draw on the resources and expertise available across the EU, avoid duplication and share workloads.

The draft strategy builds on the EMA roadmap to 2015 and the HMA strategy document 2011-15. The draft network strategy is arranged under four key themes focusing on: human health, animal health and human health in relation to veterinary medicines, optimizing the operation of the network, and the global regulatory environment.

Separate multi-annual work programs/implementation plans for EMA, HMA, and coordination groups for mutual recognition and decentralized procedures, human and veterinary (CMDh and CMDv) will be developed in order to give detailed information on the work of each component of the network, and will also describe how the strategy will be taken forward.

Source: EMA

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